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HSA · registration DE0509678

EUROIMMUN Anti-Collagen type VII ELISA (IgG)

SingaporeImmunologyClass BEUROIMMUN Medizinische Labordiagnostika AG
Official record identity
Registration number
DE0509678
Model name
Anti-Collagen type VII ELISA (IgG)
Model identifier
EA 1947-4801 G
Registration date
August 23, 2024
Classification
Risk class
Class B
Official value: CLASS B
Published category
Immunology
Published parties
Registrant / registration holder
EUROIMMUN (SOUTH EAST ASIA) PTE. LTD.
Official description

Epidermolysis bullosa aquisita (EBA). The ELISA test kit provides a semiquantitative or quantitative in vitro assay for the determination of human autoantibodies of the immunoglobulin class IgG against collagen type VII. The test kit contains microtiter strips each with 8 individual break-off reagent wells coated with collagen type VII. In the first reaction step, diluted patient samples are incubated in the wells. In the case of positive samples, the specific IgG antibodies (also IgA and IgM) will bind to the corresponding antigenic site. To detect the bound antibodies, a second incubation is carried out using an enzyme-labelled anti-human IgG (enzyme conjugate) catalysing a colour reaction.

Additional source fields
Product owner address
Seekamp 31, 23560 Lübeck, Germany
Registrant address
438A ALEXANDRA ROAD, #02-05/10, ALEXANDRA TECHNOPARK, Singapore 119967
About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.